US10737092B2 - Delivery devices and methods for leadless cardiac devices - Google Patents

Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example method for delivering the implantable leadless pacing device may include distally advancing an intermediate tubular member of a delivery system across the tricuspid valve and into the right ventricle. An outer tubular member of the delivery device may be torqued in a first direction to guide a distal holding section along the ventricular septum. The distal tip of the distal holding section may be releaseably secured to a tissue. After securing the distal tip of the distal holding section, the outer tubular member may be torqued in a second direction opposite to the first direction and the implantable leadless pacing device incrementally deployed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 62/478,897, filed Mar. 30, 2017, the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to leadless cardiac devices and methods, such as leadless pacing devices and methods, and delivery devices and methods for such leadless devices.

BACKGROUND

A wide variety of medical devices have been developed for medical use, for example, cardiac use. Some of these devices include catheters, leads, pacemakers, and the like, and delivery devices and/or systems used for delivering such devices. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices, delivery systems, and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and delivery devices as well as alternative methods for manufacturing and using medical devices and delivery devices.

BRIEF SUMMARY

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices, including delivery devices.

In a first example, a delivery device for delivering an implantable leadless pacing device may comprise an outer tubular member including a lumen extending from a proximal end to a distal end thereof, the outer tubular member may be configured to be deflectable in a first a plane, an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member may be slidably disposed within the lumen of the outer tubular member, the intermediate tubular member may include a distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and the intermediate tubular member may be configured to be deflectable in a second plane different from the first plane. The delivery device may further comprise an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member may be slidably disposed within the lumen of the intermediate tubular member, a handle assembly including at least a first hub portion may be affixed adjacent to the proximal end of the outer tubular member, a second hub portion may be affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion may be affixed adjacent to the proximal end of the inner tubular member and a first actuation mechanism may be positioned at the handle assembly and configured to deflect the outer tubular member.

Alternatively or additionally to any of the examples above, in another example, the intermediate tubular member may be deflectable about a fixed curve along a portion of a length of the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the fixed curve may include one or more nitinol wires embedded in a body of the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the delivery device may further comprise a second actuation mechanism positioned at the handle assembly and may be configured to deflect the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the delivery device may further comprise an active anchor element positioned adjacent to the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be configured to be actuated between a retracted delivery configuration and an extended fixation configuration.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be positioned along an outer surface of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be positioned within the cavity of the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may comprise a wire having an atraumatic distal tip.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be configured to engage a tissue to temporarily fixate the distal holding section to the tissue.

Alternatively or additionally to any of the examples above, in another example, a counter-clockwise torquing motion on the outer tubular member may be configured to direct an opening of the cavity towards a septal wall of a heart.

In another example, a method of separately actuating an outer tubular member affixed to a first hub portion, an intermediate tubular member affixed to a second hub portion, and an inner tubular member affixed to a third hub portion of a delivery device may comprise rotating the first hub portion in a first direction, fixating a distal end portion of the intermediate tubular portion, and after fixating the distal end portion of the intermediate tubular member to a septal wall of a heart, rotating the first hub portion in a second direction opposite the first direction.

Alternatively or additionally to any of the examples above, in another example, prior to rotating the first hub portion in the first direction, the second hub portion may be distally advanced.

Alternatively or additionally to any of the examples above, in another example, the outer tubular member may be deflectable in a first plane.

Alternatively or additionally to any of the examples above, in another example, the intermediate tubular member may be deflectable in a second plane different from the first plane.

In another example, a method of delivering an implantable leadless pacing device to a ventricular septum may comprise advancing a delivery device through the vasculature and into the right atrium. The delivery device may comprise an outer tubular member including a lumen extending from a proximal end to a distal end thereof, the outer tubular member configured to be deflectable in a first a plane, an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and the intermediate tubular member configured to be deflectable in a second plane different from the first plane, an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member, a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member. The method may further comprise distally advancing the intermediate tubular member across the tricuspid valve and into the right ventricle, torqueing the outer tubular member in a first direction to guide the distal holding section along the ventricular septum, releaseably securing a distal tip of the distal holding section to a tissue in the ventricular septum, after securing the distal tip of the distal holding section, torquing the outer tubular member in a second direction opposite to the first direction, and incrementally deploying an implantable leadless pacing device.

Alternatively or additionally to any of the examples above, in another example, the implantable leadless pacing device may be deployed such that a longitudinal axis of the implantable leadless pacing device is at an angle of in the range of 5 to 45° to the ventricular septum.

Alternatively or additionally to any of the examples above, in another example, releaseably securing the distal tip of the distal holding section to the tissue may comprise a passive anchoring of the distal tip to the ventricular septum.

Alternatively or additionally to any of the examples above, in another example, releaseably securing the distal tip of the distal holding section to the tissue may comprise an active anchoring of an active anchoring element to the ventricular septum.

Alternatively or additionally to any of the examples above, in another example, the method may further comprise unsecuring the distal tip of the distal holding section from the tissue after the implantable leadless pacing device has been at least partially deployed.

Alternatively or additionally to any of the examples above, in another example, torqueing the outer tubular member in the first direction may comprise deflecting the outer tubular member in the first plane.

Alternatively or additionally to any of the examples above, in another example, torquing the outer tubular member in the second direction opposite to the first direction may orient an opening of the distal holding section towards the ventricular septum.

In another example, a delivery device for delivering an implantable leadless pacing device may comprise an outer tubular member including a lumen extending from a proximal end to a distal end thereof, the outer tubular member configured to be deflectable in a first a plane, an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and the intermediate tubular member configured to be deflectable in a second plane different from the first plane, an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member, a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member, and a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member.

Alternatively or additionally to any of the examples above, in another example, the intermediate tubular member may be deflectable about a fixed curve along a portion of a length of the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the fixed curve may include one or more nitinol wires embedded in a body of the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the delivery device may further comprise a second actuation mechanism positioned at the handle assembly and configured to deflect the intermediate tubular member.

Alternatively or additionally to any of the examples above, in another example, the delivery device may further comprise an active anchor element positioned adjacent to the distal holding section.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be configured to be actuated between a retracted delivery configuration and an extended fixation configuration.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may comprise a wire having an atraumatic distal tip.

Alternatively or additionally to any of the examples above, in another example, the active anchor element may be configured to engage a tissue to temporarily fixate the distal holding section to the tissue.

Alternatively or additionally to any of the examples above, in another example, a counter-clockwise torquing motion on the outer tubular member may be configured to direct an opening of the cavity towards a target region.

In another example, a method of separately actuating an outer tubular member affixed to a first hub portion, an intermediate tubular member affixed to a second hub portion, and an inner tubular member affixed to a third hub portion of a delivery device may comprise rotating the first hub portion in a first direction, fixating a distal end portion of the intermediate tubular portion to a ventricular septum, and after fixating the distal end portion of the intermediate tubular member, rotating the first hub portion in a second direction opposite the first direction.

Alternatively or additionally to any of the examples above, in another example, prior to rotating the first hub portion in the first direction, the second hub portion may be distally advanced.

Alternatively or additionally to any of the examples above, in another example, the outer tubular member may be deflectable in a first plane

Alternatively or additionally to any of the examples above, in another example, the intermediate tubular member may be deflectable in a second plane different from the first plane.

The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify some of these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

FIG. 1 is a plan view of an example leadless pacing device implanted within a heart;

FIG. 2 is a side view of an example implantable leadless cardiac pacing device;

FIG. 3 is a cross-sectional view of the implantable leadless cardiac pacing device ofFIG. 2;

FIG. 4 is a plan view of an example delivery device for an implantable leadless cardiac pacing device;

FIG. 5 is a partial cross-sectional side view of the distal portion of the delivery device ofFIG. 4;

FIGS. 6A-6G are schematic views illustrating the use of the illustrative delivery device to deploy an implantable leadless cardiac pacing device;

FIG. 7 is a partial cross-sectional side view of another illustrative distal portion of the delivery device ofFIG. 4; and

FIG. 8 is a close up view of an illustrative implantable leadless cardiac pacing device passively anchoring to a septal wall.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

The following detailed description should be read with reference to the drawings in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.

Cardiac pacemakers provide electrical stimulation to heart tissue to cause the heart to contract and thus pump blood through the vascular system. Conventional pacemakers typically include an electrical lead that extends from a pulse generator implanted subcutaneously or sub-muscularly to an electrode positioned adjacent the inside or outside wall of the cardiac chamber. As an alternative to conventional pacemakers, self-contained or leadless cardiac pacemakers have been proposed. Leadless cardiac pacemakers are small capsules typically fixed to an intracardiac implant site in a cardiac chamber. The small capsule typically includes bipolar pacing/sensing electrodes, a power source (e.g., a battery), and associated electrical circuitry for controlling the pacing/sensing electrodes, and thus provide electrical stimulation to heart tissue and/or sense a physiological condition. The capsule may be delivered to the heart using a delivery device which may be advanced through a femoral vein, into the inferior vena cava, into the right atrium, through the tricuspid valve, and into the right ventricle. In some cases, it may be desirable to deliver the capsule to the ventricular septum to reduce the risk of the device perforating a chamber free wall. Accordingly, it may be desirable to provide delivery devices which facilitate advancement through the vasculature and into the heart to allow for delivery and placement to the ventricular septum.

FIG. 1 illustrates an example implantable leadless cardiac pacing device10 (e.g., a leadless pacemaker) implanted in a chamber of a heart H, such as the right ventricle RV. In some cases, thedevice10 may be affixed to the ventricular septum S, as shown. The right atrium RA, left atrium LA, left ventricle LV, and aorta A are also illustrated. Although shown implanted in the right ventricle RV, it is contemplated that theimplantable device10 may alternatively be implanted in the right atrium RA, left atrium LA, left ventricle LV, or other cardiovascular location, if desired.

A side view of the illustrativeimplantable device10 is shown inFIG. 2 and a cross-sectional view of the illustrativeimplantable device10, taken at line3-3 inFIG. 2, is illustrated inFIG. 3. Theimplantable device10 may include a shell orhousing12 having aproximal end14 and adistal end16. Theimplantable device10 may include afirst electrode20 positioned adjacent to thedistal end16 of thehousing12 and asecond electrode22 positioned adjacent to theproximal end14 of thehousing12. For example,housing12 may include a conductive material and may be insulated along a portion of its length. A section along theproximal end14 may be free of insulation so as to define thesecond electrode22. Theelectrodes20,22 may be sensing and/or pacing electrodes to provide electro-therapy and/or sensing capabilities. Thefirst electrode20 may be capable of being positioned against or may otherwise contact the cardiac tissue of the heart H while thesecond electrode22 may be spaced away from thefirst electrode20, and thus spaced away from the cardiac tissue.

Theimplantable device10 may include a pulse generator (e.g., electrical circuitry) and a power source (e.g., a battery) within thehousing12 to provide electrical signals to theelectrodes20,22 and thus control the pacing/sensing electrodes20,22. Electrical communication between the pulse generator and theelectrodes20,22 may provide electrical stimulation to heart tissue and/or sense a physiological condition.

Theimplantable device10 may include afixation mechanism24 proximate thedistal end16 of thehousing12 configured to attach theimplantable device10 to a tissue wall of the heart H, or otherwise anchor theimplantable device10 to the anatomy of the patient. As shown inFIG. 1, in some instances, thefixation mechanism24 may include one or more, or a plurality of hooks ortines26 anchored into the cardiac tissue of the heart H to attach theimplantable device10 to a tissue wall. In other instances, thefixation mechanism24 may include one or more, or a plurality of passive tines, configured to entangle with trabeculae within the chamber of the heart H and/or a helical fixation anchor configured to be screwed into a tissue wall to anchor theimplantable device10 to the heart H.

Theimplantable device10 may include adocking member30 proximate theproximal end14 of thehousing12 configured to facilitate delivery and/or retrieval of theimplantable device10. For example, the dockingmember30 may extend from theproximal end14 of thehousing12 along a longitudinal axis of thehousing12. The dockingmember30 may include ahead portion32 and aneck portion34 extending between thehousing12 and thehead portion32. Thehead portion32 may be an enlarged portion relative to theneck portion34. For example, thehead portion32 may have a radial dimension from the longitudinal axis of theimplantable device10 which is greater than a radial dimension of theneck portion34 from the longitudinal axis of theimplantable device10. The dockingmember30 may further include atether retention structure36 extending from thehead portion32. Thetether retention structure36 may define anopening38 configured to receive a tether or other anchoring mechanism therethrough. While theretention structure36 is shown as having a generally “U-shaped” configuration, theretention structure36 may take any shape which provides an enclosed perimeter surrounding theopening38 such that a tether may be securably and releasably passed (e.g., looped) through theopening38. Theretention structure36 may extend through thehead portion32, along theneck portion34, and to or into theproximal end14 of thehousing12, as is shown more clearly inFIG. 3. The dockingmember30 may be configured to facilitate delivery of theimplantable device10 to the intracardiac site and/or retrieval of theimplantable device10 from the intracardiac site.Other docking members30 are contemplated.

One aspect of the current disclosure relates to the delivery device and/or system used, for example, to deliverdevice10 to a suitable location within the anatomy (e.g., the heart). As may be appreciated, the delivery device may need to be navigated through relatively tortuous anatomy to deliver thedevice10 to a suitable location. For instance, in some embodiments, the delivery device may be advanced through the vasculature to a target region. In some example cases the device may be advanced through a femoral vein, into the inferior vena cava, into the right atrium, through the tricuspid valve, and into the right ventricle. The target region for the delivery of thedevice10 may be a portion of the right ventricle, for example, the ventricular septum. The target region may also include other regions of the heart (e.g., a portion of the right ventricle near the apex of the heart, right atrium, left atrium, or left ventricle), blood vessels, or other suitable targets. It may be desirable to provide the delivery system with certain features that may allow for easier or better control for navigation or delivery purposes.

Current delivery strategies may include delivering thedevice10 to the apical septum where the heart wall is thicker than, for example, a free wall. In such an instance, the delivery catheter may be dependent on a structure within the heart for the tip of the delivery system to rest upon. This may limit the flexibility of the system and as well as limit the ability to direct the distal end of the delivery system towards a portion of the ventricular septum that may be thicker than, for example, the apical septum and/or a free wall. Further, it may be difficult for the relatively long delivery system to steer the distal end such that it approaches the ventricular septum at an angle instead of parallel to the long axis of the ventricle. It may be desirable to provide a delivery system and delivery methods which allow the distal end of the delivery device to be oriented at more of an angle to the right ventricular septum such that thedevice10 can be deployed in the ventricular septum, in the thicker region thereof. Some illustrative delivery devices may be found in commonly assigned US Patent Publication No. 2016/0114156, titled DELIVERY DEVICES AND METHODS FOR LEADLESS CARDIAC DEVICES, US Patent Publication No. 2016/0114157, titled DELIVERY DEVICES AND METHODS FOR LEADLESS CARDIAC DEVICES, and U.S. patent application Ser. No. 15/354,432 filed on Nov. 17, 2016, titled DELIVERY DEVICES AND METHODS FOR LEADLESS CARDIAC DEVICES, the disclosures of which are incorporated herein by reference.

FIG. 4 is a plan view of anillustrative delivery device100, such as a catheter, that may be used to deliver theimplantable device10. Thedelivery device100 may include an outertubular member102 having aproximal section104 and adistal section106. An intermediatetubular member110 may be longitudinally slidably disposed within alumen150 of the outer tubular member102 (see e.g.,FIG. 5). An innertubular member116 may be longitudinally slidably disposed within alumen152 of the intermediate tubular member110 (see e.g.,FIG. 5). Adistal holding section108 may be attached to a distal end portion114 of the intermediatetubular member110. Thedelivery device100 may also include ahandle assembly120 positioned adjacent to theproximal section104 of the outertubular member102. In some embodiments, the outertubular member102 may include at least a section thereof that has an outer diameter D2 that is less than the outer diameter D1 of at least a portion of the holding section108 (see e.g.,FIG. 5).

Thehandle assembly120 may include a first ordistal hub portion126 attached to, such as fixedly attached to, theproximal end section104 of the outertubular member102, a second orintermediate hub portion128 attached to, such as fixedly attached to, a proximal end section of the intermediatetubular member110, and a third orproximal hub portion130 attached to, such as fixedly attached to, a proximal end section of the inner tubular member116 (see e.g.,FIG. 5). Thefirst hub portion126,second hub portion128, andthird hub portion130 may be positioned in a generally telescoping arrangement and longitudinally slidable relative to each other. Each of thefirst hub portion126, thesecond hub portion128, and thethird hub portion130 may be longitudinally slidable and rotatable relative to each other such that the outertubular member102, intermediatetubular member110, and innertubular member116 may be individually actuated. In some instances, it may be desirable to move the outertubular member102, intermediatetubular member110 and innertubular member116 simultaneously. Thehandle assembly120 may include a multi-stage deployment mechanism or afirst locking mechanism134 to releasably couple thesecond hub portion128 to thethird hub portion130 to prevent relative longitudinal movement therebetween, and thus prevent relative longitudinal movement between the intermediatetubular member110 and the innertubular member116. Thehandle assembly120 may also include asecond locking mechanism132 to releasably couple thefirst hub portion126 to thesecond hub portion128 to prevent relative longitudinal movement therebetween, and thus prevent relative longitudinal movement between the outertubular member102 and the intermediatetubular member110.

Thedistal holding section108 may be configured to receive theimplantable device10 therein. For example, referring toFIG. 5, which illustrates a cross-sectional view of a distal portion of thedelivery device100, the holdingsection108 may define acavity142 for slidably receiving theimplantable device10, and may include adistal opening144 for slidable insertion and/or extraction of theimplantable device10 into and/or out of thecavity142.

Thedistal holding section108 may include abody portion138 and adistal tip portion140 that may be, for example, configured to be atraumatic to anatomy, such as a bumper tip. For example, as the catheter is navigated through the anatomy, thedistal tip140 may come into contact with anatomy. Additionally, when the catheter is used to deliver the device, thetip140 of thedelivery device100 will likely come into contact with tissue adjacent the target site (e.g., cardiac tissue of the heart). A hard distal tip formed of the material of the outertubular member102 and/or intermediatetubular member110 may injure a vessel wall or cardiac tissue. As such, it may be desirable to provide thedelivery device100 with a softerdistal tip140 that can be introduced into the anatomy and come into contact with anatomy adjacent the target cite without causing unnecessary trauma.

For example, thedistal tip140 may be made of a material that is softer than thebody portion138 of thedistal holding section108. In some cases, thedistal tip140 may include a material that has a durometer that is less than the durometer of the material of thebody portion138. In some particular embodiments, the durometer of the material used in thedistal tip140 may be in the range of about 5 Shore D to about 70 Shore D, or for example, in the range of about 25 Shore D to about 65 Shore D. Additionally, thedistal tip140 may include a shape or structure that may make it less traumatic to tissue. For example, thedistal tip140 may have a distal surface, such as a tissue contacting surface, that is that is rounded or includes a curvature configured to be more atraumatic to tissue.

In some embodiments, all or a portion of thedistal holding section108 may include an inner surface that may be configured to resist getting caught on thefixation mechanism24, such as the one or more, or a plurality of hooks ortines26 on thedevice10. For example, thedistal holding section108 may include an inner layer or coating of harder or more lubricious material that resists force applied by thefixation mechanism24 onto the inner surface of thedistal holding section108. For example, thedistal holding section108 may include a multi-layered structure, and an inner layer may be made of a material that is harder than an outer layer.

The innertubular member116 may be disposed (e.g., slidably disposed) within alumen152 of the intermediatetubular member110. The innertubular member116 may be engaged by a user near or at thethird hub portion130, and extend through alumen152 of the intermediatetubular member110 and into thedistal holding section108. Adistal portion118 of the innertubular member116 may be capable of engaging thedevice10, and the innertubular member116 may be used to “push” thedevice10 out fromdistal holding section108 so as to deploy andanchor device10 within a target region (e.g., a region of the heart such as the right ventricle). The innertubular member116 may have alumen154 extending from the proximal end117 to adistal portion118 thereof. Atether112 or other retaining feature may be used to releasably secure thedevice10 to thedelivery device100. In some instances, thetether112 may be a single or unitary length of material that may extend from a proximal end117 of thelumen154, out through thedistal portion118, through theopening38 of thedevice10 and return to the proximal end117 of the innertubular member116 through thelumen154 such that both ends of thetether112 are positioned adjacent to thethird hub portion130. In some instances, the ends of thetether112 may be secured within a locking feature in thethird hub portion130.

In order to more specifically place or steer thedelivery device100 to a position adjacent to the intended target, thedelivery device100 may be configured to be deflectable or articulable or steerable. Referring toFIG. 4, for example, the outertubular member102 and/or intermediatetubular member110 may include one or more articulation or deflection mechanism(s) that may allow for thedelivery device100, or portions thereof, to be deflected, articulated, steered and/or controlled in a desired manner. For example, the outertubular member102 may include at least a portion thereof that can be selectively bent and/or deflected in a desired or predetermined direction. This may, for example, allow a user to orient thedelivery device100 such that the holdingsection108 is in a desirable position or orientation for navigation or delivery of thedevice10 to a target location. The outertubular member102 may be deflected, for example, along a deflection region.

A wide variety of deflection mechanisms may be used. In some example embodiments, deflection may be effected by one or more actuation members, such as pull wire(s) extending between a distal portion of the outertubular member102 and anactuation mechanism122 near the proximal end of the outertubular member102. As such, the one or more pull wires may extend both proximally and distally of the desired deflection or bending region or point. This allows a user to actuate (e.g., “pull”) one or more of the pull wires to apply a compression and/or deflection force to at least a portion of the outertubular member102 and thereby deflect or bend the outertubular member102 in a desired manner. In addition, in some cases the one or more wires may be stiff enough so that they can also be used to provide a pushing and/or tensioning force on the outertubular member102, for example, to “push” or “straighten” the shaft into a desired position or orientation.

In some embodiments, the actuation member takes the form of a continuous wire that is looped through or otherwise coupled to a distal end region of the outertubular member102 so as to define a pair of wire sections. Other embodiments are contemplated, however, including embodiments where the actuation member includes one or a plurality of individual wires that are attached, for example, to a metal or metal alloy ring adjacent the distal end region of the outertubular member102.

Theactuation mechanism122 may include a mechanism that may allow for applying tension (i.e. pulling force), or compression (i.e. pushing force), or both, on the actuation member(s). In some embodiments, theactuation mechanism122 may include an externalrotatable member124 connected to and rotatable about the longitudinal axis of thehandle assembly120. Therotatable member124 may threadingly engage an internal member that is attached to the proximal end of the actuation member(s) or pull wires. When the externalrotatable member124 is rotated in a first rotational direction, the internal member translates in a first longitudinal direction, thereby applying tension to the pull wire(s), which applies compression force to the shaft, so as to deflect the outertubular member102 from an initial position to a deflected position. When the externalrotatable member124 is rotated in a second rotational direction, the internal member translates in a second longitudinal direction, thereby reducing and/or releasing the tension on the pull wire(s), and allowing the outertubular member102 to relax back toward the initial position. Additionally, in some cases, as mentioned above, where the one or more wires may be stiff enough, rotation of therotatable member124 in the second rotational direction such that the internal member translates in a second longitudinal direction may apply compression to the wire(s), such that the wire(s) may apply tension to the outertubular member102 and “push” the outertubular member102 back toward an initial position, and possibly into additional positions beyond the initial position.

The one or more articulation and/or deflection mechanism(s) may also entail the outertubular member102 including structure and/or material that may provide for the desired degree and/or location of the deflection when the compressive or tensile forces are applied. For example, the outertubular member102 may include one or more sections that include structure and/or material configured to allow the shaft to bend and/or deflect in a certain way when a certain predetermined compressive and/or tensile force is applied. For example, the shaft may include one or more sections that are more flexible than other sections, thereby defining a bending or articulating region or location. Some such regions may include a number of varying or changing flexibility characteristics that may define certain bending shapes when predetermined forces are applied. Such characteristics may be achieved through the selection of materials or structure for different sections of the outertubular member102.

In other embodiments, other articulation and/or deflection mechanism(s) are contemplated. For example, all or a portion of thedelivery device100, such as the outertubular member102, may be made of a shape memory material, such as a shape memory polymer and/or a shape memory metal. Such materials, when stimulated by an actuation mechanism, such as a change in temperature or the application of an electrical current, may change or move from a first shape to a second shape. As such, these material(s) and mechanism(s) may be used to deflect or bend the outertubular member102 in a desired manner. Other suitable deflection mechanism(s) that are able to deflect thedelivery device100 may also be used. Such alternative mechanisms may be applied to all other embodiments shown and/or discussed herein, and others, as appropriate.

Furthermore, the outertubular member102 may include one or more predefined or fixed curved portion(s) along the length thereof. In some cases, such curved sections may be configured to fit with particular anatomies or be configured for better navigation or delivery of thedevice10. Additionally, or alternatively, some such curved sections may be configured to allow the outertubular member102 to be predisposed to be bent and/or deflected in a certain direction or configuration when compression and/or tension forces are applied thereto. It is contemplated that the outertubular member102 may be a laser cut metallic tubing, a braid reinforced polymeric tubing, or other flexible tubular structure as desired.

Returning again toFIG. 5, thedistal holding section108 may be affixed to a distal end portion114 of the intermediatetubular member110. Thedistal holding section108 may include ahub portion136 and atubular body portion138. In some instances, thehub portion136 may be formed from a metal or metal alloy while thebody portion138 may be formed from a polymeric material, although this is not required. In some instances, aproximal region143 of thebody portion138 may be heat bonded to adistal end portion137 of thehub portion136, or otherwise affixed. Thehub portion136 may include a taperedintermediate region145 disposed between aproximal end portion139 and thedistal end portion137.

In some embodiments, the outertubular member102 may include a metal ring or tip adjacent thedistal end103 thereof for attaching one or more pull wires thereto. It is contemplated that the outertubular member102 may further include a lubricious liner, such as, but not limited to a polytetrafluoroethylene (PTFE) liner. Theproximal end portion139 of thehub portion136 may extend proximally into thelumen150 of the outertubular member102. In some instances, an outer surface of theproximal end portion139 may form an interference fit with an inner surface of the outertubular member102. It is contemplated that the outer surface of theproximal end portion139 and the inner surface of the outertubular member102 may be coupled in a tapered engagement. For example, thedistal end103 of the outertubular member102 may flare radially outwards in the distal direction and/or theproximal end portion139 may taper radially inward in the proximal direction. The two angled surface may engage as theproximal end portion139 is proximally retracted within the outertubular member102. Other coupling arrangements may be used as desired.

It is contemplated that as the outertubular member102 is bent to navigate theimplantable device10 to the desired location, theproximal end portion139 may advance distally and disengage from the inner surface of the outertubular member102 creating a kink point or weakened region adjacent to the bonding region146. Proximally retracting the intermediatetubular member110 to bring theintermediate region145 into contact with the outertubular member102 atcontact point148 and/or bringing theproximal end portion139 into the outertubular member102 and fixing the intermediatetubular member110 in this configuration may help prevent migration of thedistal holding section108 during navigation of thedelivery device100 to the desired location. Such a configuration may also place the intermediatetubular member110 in tension while thedistal holding section108 applies a compression force on the outertubular member102, as will be discussed in more detail below. As discussed above, alocking mechanism132 in thehandle assembly120 may be utilized to releasably maintain the outertubular member102 and the intermediatetubular member110 in a desired orientation.

Referring now toFIGS. 6A-6G, an exemplary method for deploying adevice10 to, for example, the ventricular septum S using theillustrative delivery device100 will now be described with respect to the distal section anddistal holding section108. Thedelivery device100 may be introduced into the vasculature through the femoral vein through a previously introduced sheath catheter (not explicitly shown). Thedelivery device100 may be introduced through any desired location and with or without the use of an introducer sheath as desired. Thedelivery device100 may be advanced through the vasculature to the desired treatment location, which, in the case of a leadless cardiac pacing device, may be a chamber of the heart H. For example, thedelivery device100 may be advanced through the vasculature to the inferior vena cava IVC, as shown inFIG. 6A, and into the right atrium RA. The clinician may use theactuation mechanism122 to deflect thedistal end portion106 of the outertubular member102 in a desired manner to facilitate advancement and/or placement of thedelivery device100. During advancement of thedelivery device100, thehandle assembly120 may be in a fully extended configuration. In such a configuration, thethird hub portion130 may be at its proximal-most location relative to thesecond hub portion128 and thefirst hub portion126 may be at its distal-most location relative to thesecond hub portion128. When thehandle assembly120 is in its fully extended configuration, the innertubular member116, intermediatetubular member110, and the outertubular member102 may be oriented in the manner illustrated inFIG. 5. Thedelivery device100 can be imaged using known techniques to ensure accurate placement of thedevice10.

As thedistal tip portion140 of thedistal holding section108 enters the junction of the inferior vena cava IVC and the right atrium RA, the clinician may begin to deflect the outer tubular member102 (and/or intermediate tubular member110), as described above with respect toFIG. 4. It is contemplated that the outertubular member102 may be capable of deflection angles of up 180°, or more. The clinician may use a combination of skillful catheter manipulation (e.g. sweeping, rotating, etc.) and deflection to locate the tricuspid valve TV. Once the tricuspid valve TV has been located, the clinician may further advance and/or deflect thedelivery device100 to advance thedistal holding section108 into the right ventricle RV, as shown inFIG. 6B. In some instances, deflection of the outertubular member102 may be sufficient to move thedistal tip portion140 across the tricuspid valve TV and into the right ventricle RV. In other instances, the outertubular member102 may first be deflected and then thedelivery device100 pushed across the tricuspid valve TV.

Once thedistal holding section108 has been advanced across the tricuspid valve TV and into the right ventricle RV, the clinician may advance thedistal holding section108 and the intermediatetubular member110 without advancing the outer tubular member102 (i.e., telescoping the intermediate tubular member110). It is contemplated that the entiredistal holding section108 need not be in the right ventricle RV to begin advancing thedistal holding section108 and the intermediatetubular member110 without advancing the outertubular member102. For example, in some instances only a portion of the length of thedistal holding section108 may be in the right ventricle RV prior to telescoping thedistal holding section108 from the outertubular member102. It is contemplated that, in some instances, less than one-third or less than one-half of thedistal holding section108 may be positioned in the right ventricle RV when the intermediatetubular member110 is telescoped distal of the distal end of the outertubular member102. In other instances, the entire length or substantially the entire length of thedistal holding section108 may be positioned in the right ventricle RV when the intermediatetubular member110 is telescoped distal of the distal end of the outertubular member102. An average heart may have an average distance of approximately 7.5 centimeters between the tricuspid valve TV and an apex A of the right ventricle RV. In some instances, the distance between the tricuspid valve TV and the apex A of the right ventricle RV may be in the range of 4 to 12 centimeters or in the range of 6 to 10 centimeters. In a smaller heart, it may be possible for a portion of thedistal holding section108 to remain in the right atrium RA while in a larger heart thedistal holding section108 may need to be fully advanced into the right ventricle RV. For example, thedistal holding portion108 may have a length in the range of 3.5 to 5.5 centimeters or in the range of 4.0 to 5.0 centimeters. In some instances, thedelivery device100 may have a telescoping distance in the range of 3 to 10 centimeters or the in the range of 4 to 7 centimeters, for example.

Once thedistal holding section108 has been advanced, partially or fully, into the right ventricle, the handle assembly120 (e.g., the first hub portion126) may be torqued or rotated in a first direction (for example, in the clockwise direction) such that thedistal holding section108 is along the septum S, as shown inFIG. 6C. While the intermediatetubular member110 is shown in an extended or telescoped configuration, it is contemplated that thedistal holding section108 may be guided or positioned along the septum S with or without telescoping the intermediatetubular member110.

Thedistal holding section108 and the intermediatetubular member110 may be advanced until thedistal tip portion140 of thedistal holding section108 contacts the ventricular septum S of the heart H, as shown inFIG. 6C. In some cases, alongitudinal axis182 of thedistal holding section108 may be generally parallel to the septum S. For example, thelongitudinal axis182 of thedistal holding section108 may be considered generally parallel to the septum S when thelongitudinal axis182 of thedistal holding section108 is oriented at an angle A of 10° or less relative to the septum S. In other cases, thelongitudinal axis182 of thedistal holding section108 may be at any angle A between 0° (e.g., parallel to the septum S) and 90°, between 5° and 80°, between 5° and 75°, between 5° and 60°, or between 5° and 45° to the septum S. In some instances, a portion of thedistal tip portion140 may be placed in contact with the septum S of the right ventricle RV. In some instances, the location of thedistal tip portion140 may be confirmed with contrast media and imaging. For example, contrast confirmation may be used to confirm thedistal tip portion140 is engaged with a wall of the heart H prior to deploying theimplantable device10. It is further contemplated that the intermediatetubular member110 may be formed from a flexible material, such as, but not limited to a 35 D durometer polyether block amide (PEBA, for example available under the trade name PEBAX®). It is contemplated that a flexible material may buckle or flex with an applied force (e.g. from the clinician) when thedistal tip portion140 is in contact with the wall of the heart H. This may provide additional confirmation under imaging that thedistal tip portion140 is engaged with the wall of the heart H. It is further contemplated that a flexible intermediatetubular member110 may facilitate navigation of thedelivery device100.

Once thedistal tip portion140 of thedistal holding section108 has been positioned adjacent to the cardiac tissue where thedevice10 is desired, thedistal holding section108 may be temporarily anchored to the septal wall S. It is contemplated that the anchor may be a passive anchor or an active anchor, as desired. Anactive anchor190 may actuated such that it penetrates into the septal wall S, as shown inFIG. 6D. A passive anchor may include thedistal tip portion140 of thedistal holding section108 resting on or engaging a structure of the heart such as, but not limited to a base of a papillary muscle, a moderator band, trabeculae, etc., as will be described in more detail with respect toFIG. 8. Theactive anchor190 may be a manually actuated mechanism that may be deployed from thedistal holding section108 to anchor thedistal tip portion140 of thedistal holding section108 to the cardiac tissue. For example, theactive anchor190 may include a projection or penetrator configured to be actuated relative to thedistal tip portion140 of thedistal holding section108 to penetrate into the septal wall S or otherwise engage tissue. Referring briefly toFIG. 7 which illustrates a partial cross-section of thedistal holding section108 including an active anchor element, in some cases, the active anchor element may be a manually actuated atraumatic fixation mechanism orwire200. The active anchor, such aswire200, may include a fixation spike ordistal tip202 configured to engage a tissue and penetrate into the septal wall S upon actuation relative to thedistal holding section108. In some cases, thedistal tip202 may be formed as a unitary structure with thewire200. In other cases, thedistal tip202 may be formed as a separate component from thewire200 and fixedly coupled thereto. Thereby, actuation of thewire200 may deploy thedistal tip202 to penetrate into the septal wall S.

Thewire200 may be slidably disposed within alumen204. It is contemplated that thelumen204 may be formed by anadditional sidewall206 formed in addition to thebody portion138 of thedistal holding section108. Alternatively, thelumen204 may be formed within thebody portion138 of thedistal holding section108. In other cases, thewire200 and/or thelumen204 may be positioned within thecavity142 of thedistal holding section108. It is further contemplated that thewire200 may not be disposed within a separate lumen, such aslumen204. For example, thewire200 may be slidably disposed along an inner or outer surface of thebody portion138 of thedistal holding section108. It is further contemplated that thewire200 may be disposed within and/or on other components of thedelivery system100, as desired.

Thewire200 may be coupled to an actuation mechanism, for example, at the handle assembly, such that thewire200 can be manually actuated between a retracted delivery configuration and an extended fixation configuration. The actuation mechanism may be a thumb slide, a dial, a button, etc. Distal movement or advancement of thewire200 may cause thedistal tip202 of thewire200 to extending distally beyond thedistal tip portion140 of thedistal holding section108. Proximal movement or retraction of thewire200 may cause thedistal tip202 to retract proximally such that thedistal tip202 is adjacent to or proximal to thedistal tip portion140 of thedistal holding section108. It is contemplated that thedistal tip202 of thewire200 may be in the range of 0.5 millimeters to 2.5 millimeters in length and 0.5 to 1.0 millimeters in diameter. In some cases, thedistal tip202 of thewire200 may be configured to extend 0.5 millimeters to 2.5 millimeters beyond thedistal tip portion140 of thedistal holding section108 when thewire200 is in an extended or advanced configuration.

Deployment or actuation of the active anchor relative to thedistal holding section108, may anchor thedistal tip portion140 to the septal wall S at one circumferential point about thedistal tip portion140. In the case of a passive anchor, the passive anchor may anchor thedistal tip portion140 to the septal wall S at one circumferential point about thedistal tip portion140.

Once thedistal tip portion140 of thedistal holding section108 has been positioned adjacent to the cardiac tissue where thedevice10 is desired and thedistal tip portion140 is temporarily anchored, thedistal holding section108 may be steered such that theopening144 is pointed towards or generally towards the septum, as shown inFIG. 6E. For example, the handle assembly120 (e.g., the first hub portion126) may be torqued or rotated in a second direction opposite to the first direction (e.g. in a counter-clockwise direction) such that thedistal holding section108 tils relative to the septal wall S and the angle A between thelongitudinal axis182 of thedistal holding section108 and the septal wall S increases. For instance, the handle assembly120 (e.g., the first hub portion126) may be torqued or rotated in a second direction opposite to the first direction (e.g. in a counter-clockwise direction) such that the angle A between thelongitudinal axis182 of thedistal holding section108 is in the range of 5° to 90°, 10° to 85°, 15° to 85°, 15° to 75°, 30° to 75°, or 5° to 45° to the septum S. Such an increase in the angle A may enhance the apposition of thedistal tip portion140 with the septum S. However, while a greater angle may provide more direct contact of thedistal tip portion140 with the septum S, such rotation may be limited by the size (e.g., width) of the right ventricle. In some cases, the outertubular member102 may be torqued counter-clockwise while the intermediatetubular member110 is within the right ventricle. It is contemplated that an excess of intermediatetubular member110 within the right ventricle in combination with the anchoreddistal tip portion140 may cause theopening144 of thedistal holding section108 to tilt towards the septum S, as shown inFIG. 6E.

As described above, the intermediatetubular member110 may include one or more actuation or deflection mechanism(s) that may allow for the intermediatetubular member110, or portions thereof, to be deflected, articulated, steered and/or controlled in a desired manner. Such a deflection mechanism may be controlled at thehandle assembly120 to deflect thedistal holding section108 toward the septum S or in a superior and/or inferior direction, as desired. In some embodiments, the intermediatetubular member110 may include a fixed or preformed curve along any portion of the length thereof to facilitate placement of the device. A fixed or preformed curve may be enhanced or reinforced by one or more nitinol wires embedded in the body of the intermediate tubular member to help preserve the preformed shape. In some cases, the nitinol wire may be formed such that the nitinol wire assumes the curved preformed shape at body temperature, although this is not required. In some cases, the preformed curve may be biased into a generally straightened configuration by the outertubular member102. The intermediatetubular member110 may assume the preformed curved configuration as it is telescoped or distally advanced from the outertubular member102. It is contemplated that the intermediatetubular member110 may include both a deflection mechanism and a preformed curve. The deflection mechanism and/or preformed curve, when provided individually or together maybe formed such that the curves occur in a different plane than the outertubular member102. Providing mechanisms that allow thedelivery assembly100 to be curved or deflected in more than one plane may facilitate steering thedevice10 towards the septum S.

Once thedistal tip portion140 of thedistal holding section108 has been positioned adjacent to the cardiac tissue where thedevice10 is desired, deployment of thedevice10 can begin. It is contemplated that the location of thedistal tip portion140 may be confirmed with contrast media and imaging. The first stage of the deployment of thedevice10 may enable activation of thefixation mechanism24. Thedevice10 may be distally advanced out of thedistal holding section108 to deploy the hooks ortines26 from thedistal holding section108 to engage the hooks ortines26 in the heart tissue while the proximal portion of thedevice10 remains within thedistal holding section108, as shown inFIG. 6F. In some embodiments, the location and/or fixation of thedevice10 may be confirmed with contrast media, although this is not required. The second stage of the deployment of thedevice10 may proximally retract thedistal holding section108, and thus the intermediatetubular member110, relative to the innertubular member116 to fully deploy thedevice10, as shown inFIG. 6G. The temporary passive or active fixation of thedistal holding section108 may be released after the first or second stage of deployment of thedevice10, as desired. Thedevice10 may be deployed such that alongitudinal axis180 of thedevice10 is at anangle170 in the range of approximately 5° to 90°, 15° to 75°, 30° to 60°, or in the range of 5° to about 45° to the septum S. Once the clinician has determined that the position of thedevice10 is satisfactory and thefixation mechanism24 is securely engaged with the heart tissue, the intermediatetubular member110, including thedistal holding section108, of thedelivery device100 can be proximally retracted.

FIG. 8 illustrates a passive anchoring of an illustrativedistal holding section300 to the septum S. Thedistal holding section300 may be similar in form and function to thedistal holding section108 described herein and may similarly be affixed at a distal end of a delivery system. Thedistal holding section300 may include adistal tip portion302 similar in form and function to thedistal holding section140 described herein. Thedistal tip portion302 may include anannular rim304, which in some instances may include one or more protrusions or other bumps, grooves, or textured surface configured to engage the septum. Theannular rim304 may be configured to passively engage (e.g., rest upon) astructure306 of the heart such as, but not limited to a base of a papillary muscle, a moderator band, trabeculae, etc. This may provide a mechanical stop without activation of any additional structure or penetration of the septum S. It is contemplated that thedistal holding section300 may be free from any structure (e.g., annular rim304) configured to engage the heart tissue.

It is contemplated that delivering thedevice10 to the septum S allows thedevice10 to be deployed in a thicker part of the right ventricle RV which may reduce the risk of cardiac perforation. It is further contemplated that placing the pacingelectrode20 in contact with the septum S instead of the apex A may provide superior pacing. The ability to move the intermediatetubular member110 independent of the outertubular member102 may also provide greater flexibility in maneuvering thedistal holding section108 in different directions (e.g., left, right, inferior, superior, etc.) which may allow the clinician more control in the placement location of thedevice10. For example, the present delivery device and method for delivering thedevice10 may allow a clinician more consideration of the physiological characteristics of the placement location as more locations are accessible (e.g., infarcted tissue can be more readily avoided as a placement location).

While a method has been described in which thedevice10 is delivered to the right ventricular septum, it is contemplated that a similar method may be used to deliver thedevice10 to the lateral free wall of the left ventricle. For example, instead of deploying thedevice10 to the septum S, thedistal holding section108 may be advanced through a puncture or hole in the septum S, sometimes through a transatrial septal puncture. It is contemplated that thedistal holding section108 may be guided to the septum in a similar manner as described above using temporary fixation of thedistal holding section108 and manipulation of thehandle assembly120 to guide thedistal holding section108 through and/or to form the puncture.

The materials that can be used for the various components of the delivery devices, such as delivery device100 (and/or other delivery structures disclosed herein) and the various members disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference thedelivery device100, and components of thereof. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar delivery systems and/or components of delivery systems or devices disclosed herein.

Thedelivery device100 and/or other components of delivery system may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the polymer can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

In at least some embodiments, portions or all of thedelivery device100 and/or other components of delivery system may be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of thedelivery device100 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of thedelivery device100 to achieve the same result.

It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims (11)

What is claimed is:

1. A method of delivering an implantable leadless pacing device to a ventricular septum, the method comprising:

advancing a delivery device through the vasculature and into the right atrium, the delivery device comprising:

an outer tubular member including a lumen extending from a proximal end to a distal end thereof, the outer tubular member configured to be deflectable in a first a plane;

an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device, and the intermediate tubular member configured to be deflectable in a second plane different from the first plane;

an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;

a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and

a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member;

distally advancing the intermediate tubular member across the tricuspid valve and into the right ventricle;

torquing the outer tubular member in a first direction to guide the distal holding section along the ventricular septum;

releaseably securing a distal tip of the distal holding section to a tissue in the ventricular septum;

after securing the distal tip of the distal holding section, torqueing the outer tubular member in a second direction opposite to the first direction; and

incrementally deploying an implantable leadless pacing device.

2. The method ofclaim 1, wherein the implantable leadless pacing device is deployed such that a longitudinal axis of the implantable leadless pacing device is at an angle of in the range of 5 to 45° to the ventricular septum.

3. The method ofclaim 1, wherein releaseably securing the distal tip of the distal holding section to the tissue comprises a passive anchoring of the distal tip to the ventricular septum.

4. The method ofclaim 1, wherein releaseably securing the distal tip of the distal holding section to the tissue comprises an active anchoring of an active anchoring element to the ventricular septum.

5. The method ofclaim 1, further comprising unsecuring the distal tip of the distal holding section from the tissue after the implantable leadless pacing device has been at least partially deployed.

6. The method ofclaim 1, wherein torquing the outer tubular member in the first direction comprises deflecting the outer tubular member in the first plane.

7. The method ofclaim 1, wherein torquing the outer tubular member in the second direction opposite to the first direction orients an opening of the distal holding section towards the ventricular septum.

8. A method of delivering an implantable leadless pacing device to a ventricular septum, the method comprising:

advancing a delivery device through the vasculature and into the right atrium, the delivery device comprising:

an outer tubular member including a lumen extending from a proximal end to a distal end thereof;

an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member, the intermediate tubular member including a distal holding section defining a cavity therein for receiving an implantable leadless pacing device;

an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;

a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, a second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and

a first actuation mechanism positioned at the handle assembly and configured to deflect the outer tubular member;

distally advancing the intermediate tubular member across the tricuspid valve and into the right ventricle;

torquing the outer tubular member in a first direction to guide the distal holding section along the ventricular septum by rotating the first hub portion in the first direction;

releaseably securing a distal tip of the distal holding section to a tissue in the ventricular septum;

after securing the distal tip of the distal holding section, torquing the outer tubular member in a second direction opposite to the first direction by rotating the first hub portion in the second direction; and

deploying an implantable leadless pacing device from the distal holding section.

9. The method ofclaim 8, wherein the implantable leadless pacing device is deployed such that a longitudinal axis of the implantable leadless pacing device is at an angle of in the range of 5 to 45° to the ventricular septum.

10. The method ofclaim 8, wherein releaseably securing the distal tip of the distal holding section to the tissue comprises a passive anchoring of the distal tip to the ventricular septum.

11. The method ofclaim 8, wherein releaseably securing the distal tip of the distal holding section to the tissue comprises an active anchoring of an active anchoring element to the ventricular septum.

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